Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
228 participants
INTERVENTIONAL
2023-09-01
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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gemcitabine, nimotuzumab and toripalimab induction treatment
Gemcitabine at a dose of 1 g per square meter of body-surface area on days 1 and 8 every 3 weeks for two cycles.
nimotuzumanb 400mg every 3 weeks for two cycles. toripalimab 240mg every 3 weeks for two cycles.
gemcitabine,nimotuzumab, toripalimab
same as before
gemcitabine and cisplatin
Gemcitabine at a dose of 1 g per square meter of body-surface area on days 1 and 8 and cisplatin at a dose of 80 mg per square meter on day 1 were administered intravenously once every 3 weeks for two cycles.
gemcitabine, cisplatin
same as before
Interventions
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gemcitabine,nimotuzumab, toripalimab
same as before
gemcitabine, cisplatin
same as before
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Pathologically or cytologically confirmed stage III-IVB nasopharyngeal keratinizing squamous cell carcinoma or non-keratinizing squamous cell carcinoma.
3. Patients suitable for radical radiochemotherapy.
4. ECOG PS score of 0-1.
5. According to the RECIST 1.1 criteria, there is at least one measurable lesion. Basic hematological parameters are normal: white blood cell count ≥4×10\^9/L; absolute neutrophil count ≥1.5×10\^9/L; platelets ≥100×10\^9/L; hemoglobin ≥90 g/L.
6. Basically normal renal function: serum creatinine ≤1.5×ULN or creatinine clearance rate (CrCl) \> 60 mL/min (using the Cockcroft-Gault formula): For females: CrCl = (140-age) x weight (kg) x 0.85 / (72 x Scr mg/dl) For males: CrCl = (140-age) x weight (kg) x 1.00 / (72 x Scr mg/dl)
7. Basically normal liver function: serum total bilirubin ≤1.5×ULN; aspartate aminotransferase (AST) ≤2.5×ULN; alanine aminotransferase (ALT) ≤2.5×ULN.
8. Signed written informed consent.
Exclusion Criteria
2. Participated in any other interventional clinical trials within 30 days before screening.
3. History of other malignancies (except for cured skin basal cell carcinoma).
4. History of primary immunodeficiency.
5. Presence of uncontrolled concurrent diseases (such as heart failure, severe lung disease, severe liver disease, mental disease, etc.).
6. Known HIV infection, active viral hepatitis, or tuberculosis.
7. Major surgery within 90 days before the first dose of the study drug, or planned surgery.
8. Allergic to the drugs used in this protocol or their components.
9. Pregnant (confirmed by blood or urine HCG tests) or breastfeeding women, or those of childbearing age unwilling or unable to take effective contraceptive measures (applicable to both male and female subjects) until at least 6 months after the last trial treatment.
10. The investigator believes the subject is not suitable for this study.
11. Unwilling to participate in this study or unable to sign the informed consent form.
12. Live vaccinations within 30 days of dosing.
18 Years
75 Years
ALL
No
Sponsors
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Air Force Military Medical University, China
OTHER
Responsible Party
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Mei Shi
clinical professor of department of radiation oncology of XiJing hospital
Locations
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Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China
Countries
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Facility Contacts
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Other Identifiers
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AFMMUChina
Identifier Type: -
Identifier Source: org_study_id
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